Surgical drapes are used during medical procedures to create and maintain a sterile environment about the surgical site. Draping materials are selected to create and maintain an effective barrier that minimizes the passage of microorganisms between non-sterile and sterile areas. To be effective, a surgical drape barrier material should be resistant to blood, aqueous fluid, and abrasion, as lint-free as possible and drapable. When used during surgery, drapes prevent blood and other bodily fluids from contaminating the sterile field.
Various types of surgical drapes have been used to keep a surgical site on a patient sterile during a surgical procedure. Disposable drapes are usually employed. A typically disposable drape includes a two layer system: an absorbent underside layer that is directed against the patient's skin, and a liquid-impermeable layer that is constructed on top of and fixed, with adhesive, to the absorbent layer to create a two layer surgical drape. A reinforcement area is often placed around a fenestration to provide structural strength and/or to absorb fluids from the surgical site. An adhesive material may be attached to the periphery of the drape material about the fenestration to hold the drape in place around the surgical site and to minimize the passage of blood/fluids between the drape and the patient's body at the edge of the surgical opening. The combination of the drape itself and the adhesive material around the perimeter of the aperture provides for a barrier between the surgical wound and the remainder of the body. Many of today's surgical drapes are made of disposable nonwoven fabrics, plastic film, or papers.
Prior to operation, a patient is positioned upon an operating room table; and the skin surrounding the operative site is sterilized, usually with a solution containing at least 70% isopropyl alcohol. This concentration of alcohol has been tested as superior as to its rapid bactericidal properties in killing bacteria within minutes. Therefore, a necessary consequence of this disinfectant process in sterilizing the surgical site is the introduction of a compound into the operating room that is a volatile fuel for fires in and about the surgical patient and operating room staff. This fire catastrophe with disinfectant alcohol as the primary fuel occurs hundreds of times per year in the United States alone and results in significant patient death and burn injuries. Hundreds of patients annually suffer disfigurement, especially about the head and neck, resulting from burns associated with these surgical fires. Operating room physicians and other operating room staff have also received burn injuries in this circumstance and this represents a serious workplace hazard according to standards organizations and fire prevention organizations. Burns and other injuries suffered in these fires result in significant medical malpractice litigation and cost issue.
The operating room procedure for sterile prepration of the incision site is significant in the potential for fire as a necessary consequence of the surgical site sterile prep technique. The surgical drapes are specifically designed for specific types of operations, with the drape surgical opening, or fenestration of the usual size required for the designed procedure. However, it is common, without prior notice, in most procedures for the surgeon to have to enlarge the surgical site opening in the drape for greater access or to expand the operation. In this circumstance, the surgeon will cut the drape at the fenestration to enlarge it for a greater or different incision. The surgical prep personnel, aware of this possibility, routinely prep a larger skin area much larger than the usual surgical drape opening to insure that they have a sterile prep area larger than the surgical site opening in case the surgeon decides to cut the drape opening and enlarge the surgical site. Therefore, at the end of the alcohol prep, as the skin is drying from the evaporating alcohol, the surgical drape is applied with the drape surgical site over the proposed incision. Even though the skin appears to be drying, significant evaporation of alcohol is still occurring at the surgical site. Evaporation of prep alcohol is also still occurring in the area larger than the drape fenestration. However, this area is now placed under the drape that is now applied, and the alcohol molecules evaporating in this area, now under the drape at the edge of the surgical drape opening, cannot escape through the impervious drape applied. It is in this area, just at the edge of the surgical drape opening, and extending to the limits of the expanded prep area, where dangerous accumulations of alcohol molecules occur through evaporation. All that is now needed for the development of fire is an ignition spark. This is provided by the surgeon at the beginning of the procedure to provide for electrical coagulation of bleeding during the skin incision with the standard electrocautery. Fuel, oxygen and ignition equals the triad of fire. An additional hazard is that alcohol burns with a colorless flame, so that the resultant fire may not be apparent until the drape, now burning, changes color, delaying recognition of the burn damage occurring to the usually anesthetized patient's skin surrounding the incision site. This is the primary mechanism of operating room fires. The addition of supplemental oxygen by the anesthesiologist due to patient needs is a further oxidant that speeds and enriches the fire. However, in the presence of high alcohol molecule concentrations, the fire will proceed rapidly even without additional oxygen supplied and rapid fires occur with just room air. Because much of the supplemental oxygen provided to the patient is located in the neck and head area, 62% of all surgical fires occur in the head, neck, chest, and airway areas.
For a fire to occur, three elements must be present: a fuel source, oxygen, and an ignition source. As noted above, all those elements may be present during surgery, particularly in the head, neck, and chest area. Since electrosurgical cautery is a well established surgical tool to decrease blood loss, fire prevention in the operating room involves removal of the other elements of fire from the surgical area, the fuel, concentrated alcohol, and any high oxygen concentration.
Therefore, there remains a critical need for a surgical drape that contains a mechanism for removing alcohol vapors and high oxygen concentrations trapped under the drape, thereby removing that fuel source from the surgical area and minimizing operating room fire potential and patient/medical staff injury. Such an surgical drape will reduce the workplace hazards associated with high concentration alcohol prep solutions and their fire danger. The overall hazards to patients and operating room staff will be significantly reduced. Patient and staff injuries as a result of operating room fires will be reduced significantly.